AVANIR Signs Agreement with Gerolymatos to Market Docosanol 10% Cream
SAN DIEGO--(BUSINESS WIRE)--June 14, 2004--AVANIR Pharmaceuticals (AMEX:AVN) announced today that it has signed an exclusive agreement with the Gerolymatos Group of Companies to manufacture and market AVANIR's docosanol 10% cream as a treatment for cold sores in Greece, Cyprus, Turkey and Romania.
"Gerolymatos is an established Greek company with international and domestic operations and extensive experience in building strong partnerships with many of the world's leading healthcare companies," said Gerald J. Yakatan, Ph.D., AVANIR's chief executive officer and president. "Gerolymatos will be an effective partner for docosanol because of their experience with both prescription and over-the-counter products. Their complementary marketing capabilities in consumer products and cosmetics should be beneficial in marketing our topical cold sore cream."
Commenting on the new partnership, Panayotis Gerolymatus, president and chief executive officer of the Gerolymatus Group stated, "Docosanol 10% cream represents an important addition to our product portfolio. With our extensive manufacturing and marketing capabilities, we believe the product will prove to be a tremendous success in our markets."
Sold in the U.S. consumer market as Abreva(R) by AVANIR's licensee, GlaxoSmithKline, docosanol 10% cream is the only cold sore product approved by the U.S. Food and Drug Administration (FDA) that is available without a prescription. In addition to the United States, the topical treatment has been approved for marketing as a non-prescription product in Sweden, Canada, Israel and Korea. With Sweden as the Reference Member State in the European mutual recognition process, Gerolymatos and AVANIR will work together to obtain regulatory approval in Greece and Cyprus. Gerolymatos will seek regulatory approval for docosanol 10% cream in Turkey and Romania.
Under terms of the agreement, Gerolymatos will be responsible for all sales and marketing activities, as well as manufacturing and distribution of the product. The terms of the agreement provide for AVANIR to receive a data transfer fee, a potential milestone payment and royalties on product sales.
The Gerolymatos Group of Companies distributes, markets and manufactures a broad range of health care and beauty products in Greece and internationally. With an extensive array of business collaborations and alliances with leading international companies, and a rich portfolio of proprietary products, the Group commands leadership positions in the various segments in which it competes. Internationally, the Group has established a presence in several key markets through a network of distributors, subsidiaries and joint ventures with local companies. Further information about Gerolymatus can be found at www.gerolymatos.com.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. The Company's most advanced product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect, and in Phase II clinical development for neuropathic pain. A potential treatment for allergy and asthma, AVP 13358, is in Phase I clinical development. AVANIR also develops human monoclonal antibodies for infectious diseases and other therapeutic applications. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
The information contained in this press release, including any forward looking statements contained herein, should be reviewed in conjunction with the Company's Annual Report on Form 10-K, as amended, and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and such statements, including such risks and uncertainties related to drug development and clinical trials. There can be no assurance that the regulatory efforts will succeed, that docosanol 10% cream will receive required regulatory clearance or that even if such regulatory clearance were received, that such products would ultimately achieve commercial success. The company disclaims any intent or obligations to update these forward-looking statements.
CONTACT: AVANIR Pharmaceuticals
Patrice Saxon, Investor Relations, 858-622-5202
SOURCE: AVANIR Pharmaceuticals